. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/CAN/149 
21 November 2005 
 (05-5478) 
Committee on Technical Barriers to Trade Original:   English/ 
 French 
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Department of Health 
Name and address (including telephone and fax numbers, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
Canadian Enquiry Point 
200-270 Albert Street Ottawa Ontario Canada, K1P 6N7  
Tel:  (+1 613) 238 3222 
Fax:  (+1 613) 569 7808 E-mail:  info@scc.ca 
3. Notified under Article 2.9.2 [  X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:         
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in  addition, where applicable):   Prescription status of 
medicinal ingredients for human use and for veterinary use (ICS:  11.120, 11.220) 
5. Title, number of pages and langua ge(s) of the notified document:   Proposed Amendment 
to the Food and Drug Regulations (Project No. 1405 — Schedule F) (4 pages, in English and French) 
6. Description of content:   This notification announces th e availability of a letter that 
provides an opportunity to comment on the prop osed addition of 7 medicinal ingredients to 
Part I of Schedule F to the  Food and Drug Regulations . 
 
Description of the medicinal ingredients: 
1. Atazanavir and its salts  - is a protease inhibitor indicated for the treatment of 
human immunodeficiency virus (HIV), a serious and potentially life-threatening 
illness.  Individualized instructions are necessary in all potential use settings for 
atazanavir.  It is to be used only in co mbination with other Schedule F HIV drugs.  
2. Fulvestrant  - is an estrogen receptor antagonist.  It is used in the hormonal 
treatment of locally advanced or metast atic breast cancer in postmenopausal women 
in whom the disease has spread in spite  of previous endocrine therapy.  G/TBT/N/CAN/149 
Page 2  
 
3. Gefitinib  - is an enzyme inhibitor that affects the rate at which cells grow (divide) 
and die.  It is used to treat specific ty pes of lung cancer in patients who have not 
responded to other types of chemotherapy.  Gefitinib belongs to a new therapeutic 
class of drugs called epidermal growth factor receptor tyrosine kinase inhibitors. 
4. Gemifloxacin and its salts  - is a synthetic broad-spectrum antibacterial agent that 
belongs to the fluoroquinolone class of antibiotics.  Gemifloxacin is used to treat 
chronic bronchitis when caused by su sceptible strains of microorganisms. 
5. Hetastarch and its derivatives  - is a plasma volume expander administered by 
intravenous infusion to treat low blood plasma volume.  
6. Ibandronic acid and its salts  - is a bisphosphonate that acts on bone tissue to 
reduce bone resorption with no direct effect on bone formation.  Ibandronic acid is 
used to treat and prevent osteoporosis (thinning or weakening of the bones) in 
postmenopausal women.  
7. Ponazuril  - is an antiprotozoal treatment for horses.  It is used to treat equine 
protozoal myeloencephalitis (EPM), a progressive, degenerative disease of the 
central nervous system of horses caused by the protozoal parasite, Sarcocystis neurona.  
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections 
C.01.041 to C.01.049 of the Food and Drug Regulations .  Part I of Schedule F lists 
ingredients that require a prescription for human use and for veterinary use.  Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. 
The Drug Schedule Status Committee determined the necessity for prescription status for 
each of the medicinal ingredients in this pr oposed amendment on th e basis of established 
and publicly available criteria.  These crite ria include, but are not limited to, concerns 
related to toxicity, pharmacological pr operties and therapeutic applications. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human and animal health 
8. Relevant documents:   Therapeutic Products Directorate (TPD) web site:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legisl ation/acts-lois/notice-avis/index_e.html, 
Project 1405, letter posted:  14 November 2005 
9. Proposed date of adoption:   
Proposed date of entry into force:    Normally within 6 to 8 months from the 
posting of the letter on the TPD web site 
On the date the measure is adopted 
10. Final date for comments:   28 January 2006 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
The electronic version of Project No. 1405 can be downloaded at:  http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-
avis/project_projet_1405_e.html